A Prospective, Single-arm, Multi-center Clinical Study of Camrelizumab and Chemotherapy Combined With Endoscopic Surgery in the Treatment of Recurrent Nasopharyngeal Carcinoma

rNPC-SA-Neo-Cam-V1

To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma.

2021-08-10

2025-08-10

2025-08-10

Recruiting

Early phase I

100

Inclusion Criteria: * Pathologically confirmed recurrent nasopharyngeal carcinoma * American Joint Committee on Cancer recurrent rT2(recurrent T2)(including deep parapharyngeal space), recurrent T3, recurrent T4 which can be surgically removed * Age ≥18 years old * Informed consent signed * With or without lymph node metastasis, which can be surgically removed * No massive hemorrhage risk recently * No distant metastasis * ≥6 months from initial radiotherapy to recurrence * Radical radiation only once * Sufficient organ function * Eastern Cooperative Oncology Group score 0-2 Exclusion Criteria: * With a history of allergic to platinum drugs and similar compounds * Evidence of distant metastasis or radiation encephalopathy or leptomeningeal disease (LMD) * Have received radioactive seed implantation in the treatment area * Suffer from uncontrolled disease which could interfere with treatment * Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.) * The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on * The patients have autoimmune diseases * The patient is using immunosuppressive agents or systemic glucocorticoid to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other), and continues to use it within 2 weeks before the first administration * Severe allergic reaction to other monoclonal antibodies * Previously received PD-1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway) treatment * Live vaccines have been inoculated within 4 weeks before the first administration or during the study period * The patient has any situation that may hinder study compliance or the safety during the study period * Existence of serious neurological or psychiatric diseases, such as dementia and seizures * Uncontrolled active infection * Pregnant or breastfeeding women * Those who have no personal freedom and independent capacity for civil conduct * There are other situations that are not suitable for entry into the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-03-06